MAUDE Adverse Event Report: VANTIVE US HEALTHCARE LLC MINICAP WITH POVIDONE-IODINE SOLUTION; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Catalog Number	5C4466P
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a peritoneal dialysis (pd) patient experienced an unspecified infection after the patient used minicaps that were received "defective".This was further described as "'package/box open or damaged before use".It was reported that the patient was hospitalized for three days for the event.Treatment for the infection was not reported.At the time of this report, the patient outcome was not reported.Pd therapy was discontinued, the pd catheter was removed, and the patient was transferred to hemodialysis.No additional information is available.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Correction/additional information: this is a duplicate report to the report under manufacturer report number 1416980-2023-03036 (submitted on 20june2023).All relevant information was submitted under report 1416980-2023-03036.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: MINICAP WITH POVIDONE-IODINE SOLUTION
• Common Device Name: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): VANTIVE US HEALTHCARE LLC; round lake IL
• Manufacturer (Section G): VANTIVE HEALTHCARE - CUERNAVACA; calle 50 metros; civac, jiutepec morelos 62578 ; MX 62578
• Manufacturer Contact: 25212 w. il route 120; round lake, IL 60073 ; 2242706717
• MDR Report Key: 23066563
• Report Number: 8030639-2025-00025
• Device Sequence Number: 18608414
• Product Code: KDJ
• UDI-Device Identifier: 00085412007694
• UDI-Public: 0085412007694
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K152129
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 5C4466P
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2025
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 10/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male